the specifi c comparisons of placebo vs. A. paniculata 1,200 mg, placebo vs. A. paniculata 1,800 mg, and placebo vs. the combined A. paniculata dose groups were analyzed. Time to partial Mayo Score response was compared with Cox regression and the results expressed as a hazard ratio (HR), interpreted as an odds ratio with 95 % confi dence interval (CI). A cumulative incidence Kaplan – Meier plot was also created. Th e change from baseline in partial Mayo Score at weeks 2, 4, 6, and 8 by treatment group and the mean treatment diff erence (placebo minus A. paniculata with respect to change from baseline) were plotted by post-baseline visit for each treatment group along with 95 % CI at these assessment times. Th e earliest time at which the lower limit on the CI for the treatment diff erence above zero was defi ned to be the time to fi rst signifi cant partial Mayo Score diff erence. Th e mean treatment diff erences of Mayo Score change from baseline between placebo and A. paniculata treatment groups were tested using ANCOVA, with treatment as a fi xed eff ect, country/ r egion as a random eff ect, and age, gender, race, baseline value, and concomitant mesalamine use as covariates. Safety comparisons used the Fisher’ s exact test. All patients receiving at least one dose of study medication were analyzed for safety according to the treatment actually received.